® ® July 2014 Rev. No: 00 Visit www.olerup-ssp.com for “Instructions for Use” (IFU) and detailed Product Inserts HLA-B*53 101.549-06/06u 86V Gel Documentation Form and Worksheet HLA-B*53 (101.549-06/06u) Lot No: 86V Expiry Date: 2016-December-01 Name:__________________ Test Date:_______________ Review Date:_______________ Sample ID:______________ Tested By:_______________ Reviewed By:_______________ DNA Conc.(ng/ul):_________ Gel Picture PHOTO DOCUMENT Olerup SSP AB Franzengatan 5 SE-112 51 Stockholm Sweden For In Vitro Diagnostic Use Page 1 of 10 ® ® July 2014 Rev. No: 00 4 5 6 ICB 800 1070 800 1 2 800 800 800 800 1070 1070 1070 800 1070 1070 1070 1070 1070 1070 1070 1070 1070 1070 1070 1070 Am pS 145 190 150 205 125 270 3 135 290 Well No. Specific Reaction 1 2 3 7 8 170 9 75 10 150 11 85 12 105 13 90 235 4 5 6 14 95 15 16 17 18 19 20 21 22 23 24 105 160 275 140 125 60 130 205 165 NC Well No. Visit www.olerup-ssp.com for “Instructions for Use” (IFU) and detailed Product Inserts HLA-B*53 101.549-06/06u 86V 15 16 17 18 19 20 21 22 23 24 130 7 8 9 10 11 12 13 14 ‘ICB’ Internal Control Band, ‘AmpS’ Amplicon Size Interpretation:_______________ Failed lanes: _________ Comments: ___________________ Notes: Product sizes are approximate. For detailed information, see the lot-specific Specificity Table and Interpretation Table. This table is intended as a guide. For interpretation always use the Interpretation Table and/or Specificity Table. HLA-specific PCR products shorter than 125 base pairs have a lower intensity and are less sharp than longer PCR products. Primer mixes 2, 6 and 7 may have tendencies of unspecific amplifications. Primer mixes 11, 14 and 18 may give rise to a lower yield of HLA-specific PCR product than the other HLA-B*53 primer mixes. Primer mix 3 has a tendency to giving rise to primer oligomer formation. Primer mix 24 contains a negative control, which will amplify more than 95% of HLA amplicons as well as the amplicons generated by control primer pairs. PCR product sizes range from 75 to 200 base pairs. The PCR product generated by the control primer pair is 430 base pairs. Olerup SSP AB Franzengatan 5 SE-112 51 Stockholm Sweden For In Vitro Diagnostic Use Page 2 of 10 HLA-B*53 101.549-06/06u 86V Worksheet July 2014 Rev. No: 00 Well No. HLA-B allele 1,2,3 *53:01:01-53:01:10, 53:25, 53:27, 53:32, 53:34-53:35, 58:01:14 4 *53:02 *53:03, 35:203 4 *53:04 *53:05 *53:06 *53:07 *53:08:01-53:08:02 *53:09 *53:10 *53:11 *53:12 *53:13 *53:14 *53:15 *53:16 *53:17:01-53:17:02 *53:18 *53:19 *53:20 *53:21 *53:22 *53:23 *53:24 *53:26 *53:28 *53:29 *53:30, 35:01:10, 35:46-35:47, 35:207, 35:217 4 *53:31 *53:33 *07:02:01-07:08, 07:10, 07:12-07:16, 07:18:01-07:19, 07:2107:23, 07:27-07:33:03, 07:35-07:42, 07:44-07:47, 07:49N07:50, 07:52-07:59, 07:61-07:64, 07:66-07:77, 07:79, 07:8107:114, 07:116-07:130, 07:132-07:133, 07:135N-07:146, 07:148-07:154, 07:156-07:163, 07:165-07:201N, 07:20307:208, 07:210-07:219, 08:20, 08:53:01-08:53:02, 08:79, 14:03, 15:30, 15:33, 15:45, 15:63, 15:77-15:78:03, 15:116, 15:141, 15:150, 15:168, 15:233, 15:248, 15:269, 15:287, 27:25, 27:108, 27:115, 35:44, 35:118, 35:213, 39:18, 39:36, 40:15-40:16, 40:23, 40:32, 40:98, 40:161, 40:198, 44:146, 44:150, 46:01:06, 46:45, 46:54, 48:05, 48:08, 57:09, 57:13 1 2 3 4 5 6 7 Olerup SSP AB Franzengatan 5 SE-112 51 Stockholm Sweden 8 1 1 2 6 3 1 1 1 1 1 4 3 6 6 2 4 8 7 8 5 1 7 5 5 5 1 1 1 1 1 1 1 1 1 1 1 1 1 1 3 3 6 6 4 5 7 2 1 6 3 4 4 8 5 6 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 9 10 11 16 9 10 11 9 10 11 9 9 10 11 11 9 11 9 10 11 9 10 11 9 w 11 9 10 11 9 10 11 9 10 11 9 10 11 9 w 11 9 10 11 9 10 11 9 9 10 11 9 10 11 9 11 9 10 11 9 w 11 9 10 11 11 9 10 11 9 10 11 9 9 16 16 16 16 16 16 16 15 16 14 16 20 14 16 16 16 16 20 15 16 16 16 16 17 16 18 16 22 19 20 16 15 16 16 16 16 16 23 21 8 *07:09, 07:11, 07:17, 07:115 *07:20, 07:24, 07:60, 15:99, 44:76, 57:63 *07:26, 07:34, 07:43, 07:80, 07:131, 07:147, 13:20, 13:62, 14:01:01-14:02:09, 14:02:11-14:02:12, 14:04, 14:06:01-14:09, 14:11-14:18, 14:20-14:26, 14:28-14:36, 14:38-14:40, 15:0915:10:03, 15:17:01:01-15:17:02, 15:37, 15:72, 15:90, 15:177, 15:196, 15:208, 15:216, 15:230, 15:243, 15:252, 15:273, 15:313, 27:04:01-27:04:04, 27:06, 27:10, 27:15, 27:18, 27:2027:21, 27:24, 27:40, 27:54, 27:63, 27:66N, 27:68-27:69, 27:79, 27:86, 27:91-27:92, 27:100, 27:103, 27:105-27:106, 27:109, 27:112-27:114, 27:120, 38:10, 38:32, 39:35, 40:05, 40:26, 40:51, 40:95, 40:148, 40:174, 40:183, 42:19, 44:79:0144:79:02, 48:15, 49:18, 50:14, 50:20, 51:01:40, 51:104, 51:112, 51:147, 52:02:01-52:02:02, 52:16, 52:32, 55:01:04, 55:01:07, 55:17, 55:28, 55:44, 55:53, 55:58, 56:05:0156:05:02, 56:21, 57:57, 78:02:01-78:02:02 Well No. Visit www.olerup-ssp.com for “Instructions for Use” (IFU) and detailed Product Inserts Negative Control ® 8 8 8 1 2 3 4 5 6 7 8 14 20 16 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 For In Vitro Diagnostic Use Page 3 of 10 HLA-B*53 101.549-06/06u 86V Worksheet July 2014 Rev. No: 00 Well No. *07:48, 07:209, 08:13, 08:55, 13:01:01-13:01:08, 13:02:15, 13:06-13:07N, 13:11-13:13, 13:17, 13:21-13:23, 13:28-13:29, 13:35-13:36, 13:39, 13:43, 13:47, 13:50-13:52, 13:57, 13:5913:61, 13:63N-13:64, 13:71, 13:76N-13:78, 15:86, 15:162, 15:188, 15:224, 27:01-27:03, 27:05:02-27:05:18, 27:05:2027:05:28, 27:07:01-27:09, 27:11-27:14, 27:16-27:17, 27:19, 27:23, 27:26-27:37, 27:39, 27:42-27:44, 27:46, 27:48-27:51, 27:53, 27:55-27:62, 27:64N-27:65N, 27:67, 27:70-27:75, 27:77-27:78, 27:80-27:85, 27:87-27:90:02, 27:93-27:99, 27:101-27:102, 27:104, 27:110-27:111, 27:116-27:119, 27:121-27:125, 35:03:06, 35:31, 35:33, 35:65Q, 35:88, 35:230, 38:01:01-38:05, 38:08-38:09, 38:11-38:23, 38:2538:29, 38:31, 38:33-38:51, 38:53, 39:01:01:01-39:01:01:03, 39:01:03-39:06:04, 39:10:01-39:10:02, 39:12-39:17, 39:20, 39:22-39:23, 39:25N-39:31, 39:34, 39:38Q-39:42, 39:4439:73, 39:75, 39:77-39:87N, 39:89-39:90, 39:92, 40:01:0140:01:05, 40:01:07-40:02:19, 40:04, 40:06:01:01-40:06:10, 40:09-40:12, 40:14:01-40:14:03, 40:18-40:19, 40:21-40:22N, 40:24-40:25, 40:27:01-40:27:02, 40:29-40:31, 40:33-40:37, 40:39-40:40, 40:42-40:50, 40:53-40:58, 40:61-40:62, 40:6440:67, 40:69-40:70:02, 40:72:01-40:91, 40:93-40:94, 40:9640:97, 40:99-40:104, 40:107-40:127, 40:129-40:135, 40:13740:147, 40:149-40:157, 40:160:01-40:160:02, 40:163-40:173, 40:175-40:182, 40:184, 40:186-40:197, 40:199-40:208, 40:210-40:219, 40:221, 40:223-40:230, 40:233-40:248, 40:250-40:256N, 40:258-40:266, 40:268-40:278, 40:28040:283, 40:285, 44:30-44:31, 44:64:01-44:64:02, 44:92, 44:124, 44:160Q, 44:163, 47:01:01:01-47:09, 48:01:0148:01:06, 48:03:01-48:04, 48:06-48:07, 48:09-48:13, 48:1648:18, 48:20-48:22, 48:26-48:34, 54:04, 54:11, 54:15, 54:31, 55:04, 55:13, 55:27, 55:39, 55:42, 55:49, 55:61, 56:10, 56:12, 57:46, 59:02-59:03, 67:01:01-67:05, 81:01-81:07 1 *07:65 *07:78, 13:31, 54:20, 55:09, 55:21, 55:52, 55:56 *07:134 *07:164, 15:312, 27:05:19, 40:249 *08:21, 27:47, 41:17, 44:02:01:01-44:02:07, 44:02:0944:02:30, 44:05:01, 44:05:03-44:05:04, 44:08-44:09, 44:1144:12, 44:14, 44:19N-44:20, 44:22-44:25, 44:27:01-44:27:02, 44:33-44:35, 44:41:01-44:42, 44:44, 44:48-44:49, 44:5144:53, 44:55, 44:58N-44:59:02, 44:62-44:63, 44:66-44:68, 44:70-44:75, 44:78, 44:80, 44:84:01-44:84:02, 44:86-44:91, 44:93, 44:95, 44:97, 44:99-44:100, 44:104, 44:106, 44:113, 44:116, 44:118-44:119, 44:121, 44:123, 44:126:01-44:127, 44:131, 44:133, 44:136-44:139, 44:142, 44:145, 44:14844:149N, 44:151-44:152, 44:158, 44:162, 44:168-44:173, 44:177, 44:179, 44:185, 44:187, 44:191, 83:01, C*03:36, C*03:77, C*03:187 *08:25, 15:48, 27:38, 27:76, 35:04:01, 35:04:03, 35:09:0135:09:03, 35:12:01-35:12:03, 35:22, 35:34, 35:39, 35:149, 35:199, 35:201, 35:214, 35:234, 40:63, 40:92, 44:03:0144:03:16, 44:03:18-44:03:23, 44:07, 44:13, 44:26, 44:29, 44:32, 44:36-44:40, 44:45-44:47, 44:50:01-44:50:02, 44:54, 44:57, 44:60-44:61N, 44:65, 44:69, 44:77, 44:81-44:82, 44:85, 44:94, 44:98, 44:103, 44:105, 44:107-44:108N, 44:11044:111, 44:114-44:115, 44:120, 44:122, 44:125, 44:12844:130, 44:135, 44:141, 44:143, 44:147, 44:154-44:157, 44:159, 44:161, 44:164-44:165, 44:167, 44:174-44:175, 44:180-44:184, 44:186, 44:188-44:189, 44:192-44:193, 55:08, 55:51, 56:15, 57:03:01-57:03:02, 57:07, 57:17, 57:32, 57:39, 57:66, 57:70 *08:28, 08:35, 08:37, 42:09 *08:32 *08:49 *08:59:01, 37:06:01-37:06:02, 37:28 *08:60, 08:76, 42:13 *08:69, 41:18, 42:20, C*02:60, C*07:294, C*08:08:0108:08:02 Well No. 1 Olerup SSP AB Franzengatan 5 SE-112 51 Stockholm Sweden 2 3 4 5 6 7 Visit www.olerup-ssp.com for “Instructions for Use” (IFU) and detailed Product Inserts 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 16 8 8 8 19 12 18 19 w Negative Control ® 9 9 5 16 14 19 3 7 7 3 14 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 For In Vitro Diagnostic Use Page 4 of 10 ® HLA-B*53 101.549-06/06u 86V Worksheet July 2014 Rev. No: 00 *13:48, 49:01:01, 49:01:03-49:02, 49:06, 49:08-49:10, 49:1249:17, 49:19N-49:31, 50:01:01-50:01:02, 50:01:04-50:02, 50:04-50:08, 50:10-50:11, 50:13, 50:15, 50:18-50:19, 50:3450:35, 50:37-50:38, 56:25, 56:37 *13:58 *14:02:10 *14:05 *14:10, 35:96, 40:28 *14:19, 14:27, 15:133, 15:229, 15:253, 35:167, 50:09, 50:12, 50:16-50:17 Well No. Olerup SSP AB Franzengatan 5 SE-112 51 Stockholm Sweden 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 5 6 4 9 12 16 12 16 9 10 11 16 10 w 16 8 12 Negative Control Well No. *08:89, 08:107, 41:30, C*07:68, C*07:140, C*07:151, C*07:302 *08:117, C*12:87 *13:02:01-13:02:14, 13:02:16, 13:08-13:09, 13:14-13:15, 13:19, 13:27, 13:30, 13:32-13:34, 13:37-13:38, 13:40, 13:42, 13:44-13:45, 13:49N, 13:53-13:56N, 13:65-13:70, 13:7413:75, 35:60, 46:18, 54:01:01-54:02, 54:05N, 54:07-54:08N, 54:12-54:13, 54:16-54:19, 54:21-54:30, 54:32, 55:02:0155:02:08, 55:07, 55:10, 55:12, 55:16, 55:18-55:19, 55:22, 55:26, 55:30, 55:34-55:35, 55:41, 55:43, 55:46-55:48, 55:50, 55:62-55:63, 56:19N, 56:23, 59:01:01:01-59:01:01:02, 59:0559:08 *13:03, 46:11, 49:11, 54:03, 56:01:01-56:01:04, 56:01:0656:01:07, 56:07-56:08, 56:14, 56:16-56:17, 56:20:0156:20:02, 56:24, 56:26-56:30, 56:33-56:36, 56:38N-56:42, 59:04 *13:04, 15:05:01-15:05:02, 15:20, 15:91, 15:123, 15:136, 15:151, 15:155, 15:222, 15:235, 15:275, 35:01:01:0135:01:09, 35:01:11-35:01:21, 35:01:23-35:01:41, 35:05:0135:05:02, 35:07, 35:10, 35:16-35:17:02, 35:19, 35:23, 35:2535:27, 35:30, 35:32:01-35:32:02, 35:37, 35:40N-35:42:02, 35:48-35:49, 35:52, 35:54, 35:57, 35:63, 35:68:01-35:68:02, 35:71, 35:77-35:78, 35:82, 35:89-35:92, 35:94, 35:97, 35:101:01-35:101:02, 35:103-35:104, 35:107, 35:108:02, 35:110-35:113, 35:116, 35:119-35:126, 35:130N-35:134N, 35:137-35:139, 35:143-35:145N, 35:147-35:148, 35:159, 35:161, 35:165N, 35:168, 35:170-35:171, 35:173N, 35:175, 35:177-35:178, 35:189, 35:191, 35:194, 35:196, 35:200, 35:202, 35:209-35:210, 35:212, 35:215-35:216N, 35:21835:219, 35:222, 35:224, 35:227-35:228, 35:238-35:241, 35:244-35:245, 35:247-35:250, 35:252-35:254, 44:43:0144:43:02, 46:13:01-46:13:03, 46:19, 46:33, 46:43, 48:02:0148:02:03, 56:09, 57:01:01-57:01:02, 57:01:04, 57:01:0657:01:11, 57:01:13-57:01:16, 57:01:18, 57:06, 57:08, 57:1057:11, 57:15-57:16, 57:18, 57:20-57:21, 57:23, 57:29, 57:3357:38, 57:40, 57:44-57:45, 57:48-57:56, 57:58-57:62, 57:65, 57:67-57:69, 58:36, 58:44 *13:10 *13:16, 14:37, 15:42, 49:07, 50:31, 55:01:01-55:01:03, 55:01:05-55:01:06, 55:01:08-55:01:12, 55:03, 55:05, 55:11, 55:15, 55:24-55:25, 55:29, 55:31, 55:33, 55:36, 55:38, 55:40, 55:45, 55:55N, 55:59-55:60, 55:64 *13:18, 13:41, 45:08, 45:10, 54:10, 55:37, 55:57 *13:25 *13:26:01-13:26:02, 13:72, 15:52, 15:114, 15:124, 15:186, 27:41, 35:01:22, 35:15, 35:93, 35:140, 35:180, 38:52, 39:07, 39:91, 40:222, 46:21:01-46:21:02, 48:14, 54:09, 54:14, 55:23, 55:32, 56:18, 57:01:03, 57:01:12, 57:25-57:26, 57:43, 57:64 Visit www.olerup-ssp.com for “Instructions for Use” (IFU) and detailed Product Inserts 16 12 6 16 10 11 4 8 5 8 8 8 2 4 1 2 3 4 8 5 6 7 8 16 12 16 12 15 16 w 14 16 16 16 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 For In Vitro Diagnostic Use Page 5 of 10 July 2014 Rev. No: 00 Well No. 1 *15:01:01:01-15:01:04, 15:01:06-15:01:35, 15:04:0115:04:02, 15:08:01-15:08:02, 15:11:01-15:12, 15:14-15:15, 15:19, 15:24:01-15:24:02, 15:26N-15:28, 15:34-15:35, 15:43, 15:46-15:47:02, 15:49-15:50, 15:53-15:54, 15:56-15:57, 15:60, 15:66, 15:70-15:71, 15:76, 15:79N, 15:81-15:82, 15:85, 15:87, 15:92, 15:94N, 15:96-15:97, 15:101-15:102, 15:104, 15:109-15:110, 15:113, 15:117-15:118, 15:120, 15:122, 15:125-15:126, 15:129, 15:135, 15:140, 15:142-15:143, 15:146-15:149N, 15:152, 15:154, 15:157, 15:159-15:160, 15:163-15:167, 15:169, 15:171-15:172, 15:174-15:175, 15:178, 15:180-15:184, 15:187, 15:189-15:193, 15:201, 15:203, 15:205-15:207, 15:209N, 15:211-15:212, 15:215, 15:217, 15:225, 15:227-15:228, 15:231-15:232, 15:234, 15:236, 15:241, 15:244-15:247, 15:249, 15:251, 15:25615:262N, 15:264, 15:267, 15:270, 15:272N, 15:276-15:280, 15:284-15:286, 15:295-15:296, 15:298, 15:300, 15:304N15:305, 15:309, 15:315-15:318, 15:320, 35:14:01-35:14:02, 35:43:01, 35:67, 35:79, 35:86, 35:102, 35:117, 35:135, 35:185, 46:01:01-46:01:05, 46:01:07-46:01:16, 46:01:1846:05, 46:07N, 46:10, 46:14-46:17, 46:20, 46:22-46:24, 46:2746:32, 46:34-46:39, 46:41N-46:42, 46:44, 46:46-46:53, 46:55N-46:57, 54:06, 56:03 *15:02:01-15:02:09, 15:06, 15:13:01-15:13:02, 15:21, 15:25:01-15:25:03, 15:36, 15:44, 15:89, 15:106, 15:112, 15:121, 15:139, 15:156, 15:170, 15:204, 15:213-15:214, 15:240, 15:265, 15:271, 15:289, 15:291, 15:297, 15:30115:302N, 15:319, 49:05 *15:03:01-15:03:04, 15:16:01-15:16:03, 15:18:01-15:18:06, 15:23, 15:29, 15:39:01-15:40, 15:61-15:62, 15:64:0115:64:02, 15:67, 15:69, 15:74, 15:80, 15:93, 15:95, 15:98, 15:103, 15:108, 15:119, 15:127, 15:131-15:132, 15:134, 15:138, 15:153, 15:158, 15:161, 15:173, 15:194-15:195, 15:197-15:198, 15:210, 15:219-15:220, 15:223, 15:226N, 15:238, 15:242, 15:254-15:255, 15:263, 15:266, 15:268, 15:274, 15:281-15:282, 15:288, 15:290, 15:292-15:294N, 15:306-15:307, 15:310-15:311, 15:314, 27:107, 35:11:0135:11:03, 40:158, 46:08, 48:25, 49:04, 50:33, 56:32, 57:22 *15:07:01-15:07:03, 15:68, 46:12 *15:31, 15:283, 44:144, 57:41 *15:32:01-15:32:02, 15:299 *15:38:01-15:38:02 *15:51, 15:179:01-15:179:02, 35:115, 44:17, 45:09, 57:24 *15:55 *15:58, 15:73, 15:137 *15:65, 15:221, 35:99 *15:75, 15:105, 15:111N, 15:145 *15:84, 15:237, 35:08:01-35:08:07, 35:45, 35:61:01-35:61:02, 35:80, 35:100, 35:105, 35:142, 35:158, 35:176, 35:187, 35:192, 35:206, 35:225, 57:19 *15:88, 15:250 *15:107, 35:53N, 35:64:01-35:64:02, 35:114, 57:01:05, 57:31, 57:47 *15:115 *15:128, 15:144 *15:176, 15:200 *15:185 *15:199 *15:202, 15:239 *15:218Q *15:303, 50:01:03, 50:32 *15:308 *18:01:01:01-18:01:03, 18:01:05-18:02, 18:05-18:06, 18:08, 18:12, 18:17N, 18:23N-18:24, 18:27-18:28, 18:31-18:32, 18:34, 18:38-18:39, 18:42-18:47, 18:49-18:53, 18:55, 18:5918:60, 18:62-18:65, 18:70-18:78, 18:80-18:100, 18:10218:103 *18:01:04, 18:40 Well No. 1 Olerup SSP AB Franzengatan 5 SE-112 51 Stockholm Sweden HLA-B*53 101.549-06/06u 86V Worksheet 2 3 4 5 6 7 7 6 Visit www.olerup-ssp.com for “Instructions for Use” (IFU) and detailed Product Inserts 8 8 11 8 w 16 8 11 16 8 11 9 10 w 11 11 9 11 9 10 w 8 8 5 4 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 8 8 9 14 16 14 16 11 11 20 w 11 20 w 6 8 8 6 5 8 8 5 4 8 8 6 2 3 4 5 6 6 7 8 Negative Control ® w 9 10 16 11 w 11 9 10 11 11 11 11 16 w 16 15 12 w 15 16 10 11 15 16 18 10 15 16 18 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 For In Vitro Diagnostic Use Page 6 of 10 HLA-B*53 101.549-06/06u 86V Worksheet July 2014 Rev. No: 00 Well No. *18:03 *18:04, 18:25, 18:68 *18:07:01-18:07:02, 18:29, 18:33, 18:79 *18:09 *18:10-18:11, 18:35 *18:13 *18:14 *18:15, 18:57 *18:18 *18:19, 18:30 *18:20 *18:21 *18:22, 18:69 *18:26, 18:41, 18:61, 40:209 *18:36 *18:37, 18:48, 18:66, 39:43, 56:31 *18:54 *18:56 *18:58 *18:67 *18:101 *27:52 *35:02:01-35:02:06, 35:83, 35:129N, 35:182-35:184, 35:211, 35:220 *35:03:01-35:03:05, 35:03:07-35:03:14, 35:06, 35:13, 35:36, 35:55-35:56, 35:59, 35:70, 35:74-35:75, 35:85, 35:98, 35:106, 35:127-35:128, 35:150-35:153, 35:155, 35:160, 35:179, 35:181, 35:193, 35:195, 35:198, 35:204-35:205, 35:221, 35:223, 35:235-35:236, 35:242-35:243, 35:246, 39:32, 39:74, 40:71, 44:10, 44:178, 56:02, 56:04, 56:11, 56:22 *35:04:02, 35:251, 78:04 *35:05:03, 35:51 *35:18, 35:164, 44:28:01-44:28:02, 57:02:01-57:02:02, 57:0457:05, 57:12, 57:28N, 57:42 *35:20:01-35:20:02, 35:28, 35:226 *35:21, 35:188 *35:24:01-35:24:02 *35:29:01-35:29:02, 35:69, 35:76 *35:35 *35:38, 35:163, 35:169, 38:30, 44:140, 45:02, 82:01-82:03, C*04:34 *35:50, 35:197 *35:58 *35:62, 57:27 *35:66 *35:72 *35:81 *35:84, 35:231 *35:95 *35:108:01 *35:109 *35:136 *35:141, 46:25 *35:146 *35:154 *35:156, 39:33 *35:157 *35:162 *35:166 *35:172 *35:174 *35:186 *35:190 *35:208 *35:229 *35:232 *35:233 *35:237 Well No. Olerup SSP AB Franzengatan 5 SE-112 51 Stockholm Sweden 1 2 3 4 5 5 6 6 6 6 6 6 6 6 6 6 6 7 Visit www.olerup-ssp.com for “Instructions for Use” (IFU) and detailed Product Inserts 8 8 7 8 8 2 6 6 6 6 3 5 1 3 6 8 3 4 9 10 10 10 10 10 10 w 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 11 15 16 18 19 11 15 16 11 16 18 11 15 16 18 11 15 16 18 11 15 18 11 14 15 16 18 11 15 16 18 10 11 15 16 18 11 15 18 10 w 15 16 18 15 18 10 11 15 16 18 15 16 18 9 10 11 15 16 18 10 11 16 10 11 15 16 18 9 11 15 18 9 10 11 15 16 18 10 11 15 16 18 11 15 16 18 16 18 9 16 9 16 9 9 10 11 14 22 16 16 21 9 2 2 6 6 8 4 20 9 10 11 11 9 10 11 9 10 11 w 11 15 16 16 16 16 16 2 4 7 4 4 4 9 10 11 11 9 w 11 w 11 9 10 11 9 9 9 9 10 11 9 9 9 11 9 10 11 9 9 14 2 6 8 2 1 2 3 5 6 7 8 9 9 10 11 9 9 w 9 10 11 10 11 9 10 11 9 w 11 11 9 16 16 14 14 15 16 16 16 15 16 16 16 16 16 16 16 18 22 18 22 19 22 21 22 20 2 4 4 19 9 8 2 Negative Control ® 16 16 18 22 20 20 16 16 16 14 22 w 23 19 20 20 16 16 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 For In Vitro Diagnostic Use Page 7 of 10 ® HLA-B*53 101.549-06/06u 86V Worksheet July 2014 Rev. No: 00 *37:01:06 *37:02 *37:04:01-37:04:02 *37:07 *37:09, 37:12, 37:19, 37:44 *37:10 *37:11, 37:14, 37:29 *37:13 *37:21, 37:26 *37:31, 37:42N *37:34 *37:35 *37:37 *37:39 *37:40 *37:48 *38:06-38:07 *39:09:01-39:09:02, 39:88 *39:19:01-39:19:02 *39:24:01-39:24:02, 39:37, 39:76 *40:01:06, 40:07-40:08, 40:13, 40:68, 40:106, 40:162, 40:220, 40:232 *40:03, 40:267, 40:284 *40:20, 40:38, 40:52, 40:59-40:60, 40:105, 40:159, 46:06, 48:23 *40:185 *41:24 *44:02:08, 44:101 *44:03:17 *44:06, 51:08:01-51:08:02, 51:44N, 51:141 *44:15 *44:18, 45:01:01-45:01:02, 45:04-45:07, 45:13-45:14, 56:13, 56:43 *44:83, 44:134 *44:96, 44:153 *44:109 *44:117 *44:176 *44:190, C*15:39 *45:03 *45:11 *45:12 *46:09, 57:01:17 *46:26 *46:40 *49:01:02 *49:03, 52:25 *50:36 *51:01:01-51:01:39, 51:01:41-51:01:46, 51:01:48-51:03, 51:06:01-51:06:02, 51:11N-51:12, 51:14, 51:16-51:18, 51:2151:24:05, 51:26-51:28, 51:30, 51:32-51:35, 51:38-51:39, 51:41N, 51:43, 51:48-51:52, 51:58-51:60, 51:64-51:71, 51:7551:77, 51:79-51:80, 51:83-51:86, 51:88-51:90, 51:94-51:96, 51:98N-51:102, 51:105, 51:107, 51:109-51:111, 51:11351:114, 51:117-51:119, 51:121, 51:123-51:138, 51:140, 51:142-51:146, 51:149N-51:152, 51:154-51:156, 51:15851:171, 51:173Q, 52:01:13, 52:06:01-52:06:02, 52:22-52:23 *51:01:47, 51:36, 51:55, 51:61:01-51:61:02, 51:82 *51:04, 51:46, 51:56:01-51:56:02 *51:05 *51:07:01-51:07:02, 52:01:01:01-52:01:12, 52:01:1452:01:19, 52:04-52:05, 52:07-52:08, 52:11-52:13, 52:15, 52:17-52:18, 52:26-52:27, 52:30-52:31:02, 52:33-52:38 *51:09:01-51:09:02, 51:40, 51:73, 51:108, 51:122 Well No. Olerup SSP AB Franzengatan 5 SE-112 51 Stockholm Sweden 1 2 3 4 5 6 3 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 7 15 18 15 16 15 15 15 15 15 15 18 18 18 18 18 18 18 18 18 7 2 3 3 3 3 7 8 5 7 7 7 7 7 7 7 7 7 7 7 3 3 3 1 3 3 3 3 5 4 4 8 15 15 15 15 15 15 16 15 16 16 16 14 16 11 9 9 1 7 18 18 18 19 18 20 18 18 18 18 19 16 10 14 21 16 10 16 15 16 5 11 1 4 6 4 5 14 w w 9 9 12 9 12 16 9 9 9 9 9 6 w 6 Negative Control Well No. *37:01:01-37:01:05, 37:01:07-37:01:09, 37:03N, 37:05, 37:08, 37:15-37:18, 37:20, 37:22-37:25, 37:27, 37:30N, 37:3237:33N, 37:36, 37:38, 37:41, 37:43, 37:45-37:47, 37:49 Visit www.olerup-ssp.com for “Instructions for Use” (IFU) and detailed Product Inserts 15 16 16 23 2 9 4 4 8 8 8 8 8 4 4 4 1 1 1 1 1 w w 15 16 16 16 9 8 2 3 4 5 6 7 8 22 16 8 8 2 22 16 12 12 12 8 1 1 1 9 9 11 9 10 11 11 12 12 12 20 w 15 16 9 16 21 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 For In Vitro Diagnostic Use Page 8 of 10 HLA-B*53 101.549-06/06u 86V Worksheet July 2014 Rev. No: 00 Well No. *51:10, 51:81, 51:115 *51:13:01-51:13:02, 51:62, 51:92, 51:106, 51:172 *51:15 *51:19, 51:42, 51:148 *51:20 *51:29 *51:31, 51:93 *51:37, 51:45, 51:63 *51:53, 51:120 *51:54 *51:57, 51:103, 51:116 *51:72, 51:87, 51:91 *51:74 *51:78:01-51:78:02 *51:97 *51:139 *51:153 *51:157 *52:01:20 *52:03, 52:10:01-52:10:03 *52:09 *52:14 *52:19 *52:20 *52:21 *52:24 *52:28-52:29 *52:39 *55:14 *55:54 *56:01:05 *56:06, 78:01:01-78:01:02, 78:03, 78:07 *57:14 *57:30 *58:01:01-58:01:02, 58:01:04-58:01:13, 58:01:15-58:02, 58:04, 58:07, 58:10N-58:13, 58:15-58:16:02, 58:18, 58:21, 58:23-58:26, 58:29, 58:31N-58:32, 58:39N-58:43, 58:45:0158:45:02, 58:47-58:59 *58:01:03 *58:05 *58:06, 58:19 *58:08:01-58:08:02, 58:46 *58:09 *58:14 *58:17N *58:20, 58:27 *58:22 *58:28 *58:33 *58:34 *58:35, 58:37-58:38 *78:05-78:06 A*02:188, A*24:174 C*02:56, C*06:20, C*07:81 C*03:19, C*03:26, C*03:102 C*03:28, 03:49, C*14:20 C*04:08, C*04:147, C*05:39 C*05:27, C*08:41, C*15:15, C*17:07 C*07:168 C*07:342, C*14:53 Well No. 1 1 1 1 1 1 1 1 1 1 2 3 4 5 6 7 4 4 Visit www.olerup-ssp.com for “Instructions for Use” (IFU) and detailed Product Inserts 8 8 8 6 8 5 1 1 1 1 1 1 1 1 1 1 1 1 5 5 8 8 8 8 6 2 9 10 11 12 13 14 15 16 17 18 19 20 16 16 9 12 16 9 16 9 19 20 16 11 16 w 9 20 16 18 w 16 16 9 11 9 16 12 8 15 15 15 15 15 15 15 15 15 15 9 3 8 8 4 9 5 1 1 1 1 8 8 8 6 8 8 11 11 12 12 9 8 2 6 9 10 11 11 16 w 16 16 16 16 1 1 1 1 1 1 9 10 13 13 13 13 13 13 13 13 13 13 13 13 13 16 16 16 16 16 16 16 16 6 1 1 1 1 1 1 9 10 11 9 10 11 9 10 11 9 w 11 9 9 10 11 9 10 11 4 4 8 21 21 21 23 19 23 20 13 2 w 20 w 16 16 w 16 16 16 9 10 11 8 8 21 16 1 11 11 21 22 23 24 Negative Control ® 23 20 16 16 16 16 15 16 w w w 20 20 4 4 7 1 2 3 4 5 6 7 8 w 10 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 1HLA-B*53 alleles in bold lettering are listed as confirmed alleles on the on the IMGT/HLA web page www.ebi.ac.uk/imgt/hla, release 3.16.0, April 2014. 2Alleles that have been deleted from or renamed in the official WHO HLA Nomenclature up to and including the last IMGT/HLA database release can be retrieved from web page http://hla.alleles.org/alleles/deleted.html. Olerup SSP AB Franzengatan 5 SE-112 51 Stockholm Sweden For In Vitro Diagnostic Use Page 9 of 10 ® July 2014 Rev. No: 00 HLA-B*53 101.549-06/06u 86V Worksheet Visit www.olerup-ssp.com for “Instructions for Use” (IFU) and detailed Product Inserts 3Primer mix 3: Specific PCR fragment of 135 bp in the B*53:03, 53:05, 53:16 and 53:33 and the B*18:54, 18:67, 27:52, 35:203, 37:01:01-37:01:05, 37:01:07-37:05, 37:07-37:09, 37:12-37:13, 37:15-37:27, 37:30N-37:33N, 37:35-37:36, 37:3837:49 and 52:09 alleles. Specific PCR fragment of 290 bp in the B*53:15 and the B*08:49, 08:60, 08:76 and 42:13 alleles. Primer mix 6: Specific PCR fragment of 205 bp in the B*53:02, 53:06 and 53:28 and the B*15:38:01-15:38:02, 15:185, 18:01:01:01-18:09, 18:12-18:15, 18:17N-18:20, 18:22-18:25, 18:27-18:34, 18:36-18:40, 18:42-18:55, 18:57, 18:59-18:60, 18:62-18:100, 18:102-18:103, 35:21, 35:24:01-35:24:02, 35:188, 35:190, 39:43, 51:37, 51:45, 51:63, 51:97, 52:39, 56:31, 57:14 and 58:09 and in the C*12:87 alleles. Specific PCR fragment of 235 bp in the the B*53:05, 53:12 and 53:16 and the B*08:117, 13:25, 15:115, 44:15, 44:109 and 44:176 alleles. Primer mix 14: Specific PCR fragment of 95 bp in the B*53:14 and the B*07:09, 07:11, 07:17, 07:115, 08:28, 08:35, 08:37, 08:69, 14:05, 15:07:01-15:07:03, 15:55, 15:68, 18:14, 35:05:03, 35:51, 35:58, 35:66, 35:72, 35:232, 39:24:01-39:24:02, 39:37, 39:76, 40:03, 40:267, 40:284, 41:18, 41:24, 42:09, 42:20 and 46:12 and in the C*02:60, C*07:294 and C*08:08:0108:08:02 alleles. Specific PCR fragment of 130 bp in the B*53:10 allele. ‘w’, may be weakly amplified. 4The B*53:01:01-53:01:10, 53:25, 53:27, 53:32, 53:34-53:35 and the B*58:01:14 alleles give rise to identical amplification patterns with the HLA-B*53 subtyping kit. These alleles can be distinguished by the HLA-B low resolution kit and/or the HLAB*58 subtyping kit. The B*53:03 and the 35:203, the B*53:30 and the 35:01:10, 35:46-35:47, 35:207 and 35:217 alleles give rise to identical amplification patterns with the HLA-B*53 subtyping kit. These alleles can be distinguished by the HLA-B low resolution kit and/or the HLA-B*35 subtyping kit. The HLA-B*53 subtyping cannot distinguish the following silent mutations: the B*53:01:01-53:01:10 alleles, the B*53:08:0153:08:02 or the B*53:17:01-53:17:02 alleles. Olerup SSP AB Franzengatan 5 SE-112 51 Stockholm Sweden For In Vitro Diagnostic Use Page 10 of 10